BASS: Reduction of Prehospital Delays in Stroke and Transient Ischaemic Attack (TIA)

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT00744029
Collaborator
German Federal Ministry of Education and Research (Other)
1,388
1
2
40
34.7

Study Details

Study Description

Brief Summary

In patients with acute stroke, systemic thrombolysis needs to be administered within three hours of symptom onset. The aim of the present study was to reduce prehospital delays in a population-based intervention.The intervention consisted of an educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (EMS). The investigators additionally included a bookmark and sticker with the EMS telephone number. A total of 75,720 inhabitants received the intervention. Between 2004 and 2005, 741 patients with cerebrovascular events were admitted from the control areas (n=24) and 647 from the intervention areas (n=24).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: educational material
N/A

Detailed Description

Background and Purpose:

In patients with acute stroke, systemic thrombolysis needs to be administered within three hours of symptom onset. The aim of the present study was to reduce prehospital delays in a population-based intervention.

Methods:

We performed a cluster-randomized trial with 48 zip code areas as cluster units in the catchment area of three inner-city hospitals in Berlin. The primary endpoint was time between symptom onset and hospital admission. The intervention consisted of an educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (EMS). We additionally included a bookmark and sticker with the EMS telephone number. We fitted a lognormal survival regression model (time-to-admission) with frailty terms shared by inhabitants of the same zip code area.

Study Design

Study Type:
Interventional
Actual Enrollment :
1388 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Population-Based Intervention to Reduce Prehospital Delays in Patients With Stroke and Transient Ischaemic Attack
Study Start Date :
Feb 1, 2004
Actual Primary Completion Date :
Dec 1, 2005
Actual Study Completion Date :
Jun 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intervention group

Educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (EMS) as well as a bookmark and sticker with the EMS telephone number.

Behavioral: educational material
Educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (EMS) as well as a bookmark and sticker with the EMS telephone number.

No Intervention: Control group

No intervention was performed

Outcome Measures

Primary Outcome Measures

  1. Time between symptom onset and hospital admission [Admission to hospital]

Secondary Outcome Measures

  1. Proportion of patients with thrombolysis [hospital stay]

  2. Mortality [hospital stay]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All patients with stroke or transient ischaemic attacks from the postal code areas of the study being admitted to one of the participating hospitals
Exclusion Criteria:
  • Patients with stroke or transient ischaemic attacks from outside the postal code areas of the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Social Medicine, Epidemiology and Health Economics Berlin Germany 10098

Sponsors and Collaborators

  • Charite University, Berlin, Germany
  • German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Stefan N Willich, MD, Institute for Social Medicine, Epidemiology and Health Economics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00744029
Other Study ID Numbers:
  • Project Z1b
First Posted:
Aug 29, 2008
Last Update Posted:
Sep 1, 2008
Last Verified:
Aug 1, 2008
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2008